FDA Approves BromSite, Sun Pharma's Ophthalmic Drug
On April 9, 2016, Sun Pharma announced that it has received US FDA approval for one of its wholly-owned subsidiaries, approving 0.075% of BromSite ™ (Bromfenac Sodium Eye Drops) to treat Postoperative Inflammation And to prevent eye pain in patients with cataract surgery. BromSite ™ is the first non-steroidal anti-inflammatory drug (NSAID) approved by the FDA for postoperative inflammation and prevention of eye pain in patients after cataract surgery and is currently used to treat inflammation and reduce pain.
Developed by InSite Vision's DuraSite ™, BromSite ™ is the first bromfenac sodium ophthalmic solution based on a polymer formulation to improve solubility, absorption, bioavailability and residence time compared to conventional topical therapies. In November 2015, Sun Pharmaceutical acquired InSite Vision and plans to commercialize BromSite ™ in the United States in the first half of 2016 through a new format. According to the January 2016 IMS data, the non-steroidal anti-inflammatory drug ophthalmic market in the United States increased by 8%, about the same as the January 2016 IMS (Rolling full year data: the sum of the data of the previous 12 months dating back to the specified time point) 400 million prescriptions, 4 million US dollars in sales, increased participation of Sun Pharmaceutical interest.
BromSite's approval laid a commercial milestone for Sun Pharmaceutical. Sun Pharmaceutical purposely provides eye care practitioners, enhances the patient's practice form, and provides patients with treatment options. With the approval of BromSite and its pipeline later, Sun Pharmaceuticals is now offering a range of beneficial products at a steady pace, building itself into a respected and trusted partner.
In two multicenter, randomized, controlled trial of Phase III studies, patients treated with BromSite did not find pain at a higher rate (77% vs. 82%) 1 day after surgery compared to 48% in the control group And 62%, respectively (p <0.001). In addition, BromSite-treated patients showed a higher proportion of patients with no inflammation (57% vs 38%) after cataract surgery 15 days compared with only 19% and 22% of controls (p <0.001, p = 0.035).
Dr. Richard L. Lindstrom, MD, a professor of ophthalmology at the University of Minnesota and an ophthalmologist in Minnesota and an eye physician, said that over the years they have worked closely with the InSite team to develop several high-quality products through the DuraSite platform. Today, I am pleased to see BromSite ™ on the market. I am convinced that this new product will bring great benefits to clinicians. As the first FDA-approved label for non-steroidal anti-inflammatory drugs to prevent pain and reduce post-cataract inflammation, BromSite's approval is timely and will be well received by patients and clinicians.